Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Purdue Pharma

Status and phase: Terminated; Phase 3

Conditions: Back Pain Lower Back Chronic

Treatments: Drug: Buprenorphine; Drug: Oxycodone Immediate-Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313014

BUP3015

Details and patient eligibility

About

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Full description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• low back pain for 3 months or longer, confirmed by radiographic evidence.
• receiving a stable dose of an opioid analgesic for low back pain.

Exclusion criteria

• taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.

Other protocol-specific exclusion/inclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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660 participants in 3 patient groups

BTDS 5

Active Comparator group

Description:

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.

Treatment:

Drug: Buprenorphine

Drug: Buprenorphine

BTDS 20

Experimental group

Description:

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Treatment:

Drug: Buprenorphine

Drug: Buprenorphine

Oxycodone Immediate-Release

Experimental group

Description:

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Treatment:

Drug: Oxycodone Immediate-Release